GASTROSTOMY CATHETER E3320

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-11-16 for GASTROSTOMY CATHETER E3320 manufactured by Rusch Inc.

Event Text Entries

[17433209] Balloons burst on two gastrostomy tubes, one after one day and the second after three days. Since they could not get the gastrostomy tubes to operate correctly, they used a silicone coated latex foley catheter to feed the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-1998-00073
MDR Report Key197900
Report Source08
Date Received1998-11-16
Date of Report1998-11-16
Date of Event1998-07-01
Date Mfgr Received1998-10-28
Date Added to Maude1998-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGASTROSTOMY CATHETER
Generic NameTRIPLE PORT GASTROSTOMY CATHETER
Product CodeKDH
Date Received1998-11-16
Model NumberNA
Catalog NumberE3320
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key192268
ManufacturerRUSCH INC
Manufacturer Address2450 MEADOWBROOK PKWY DULUTH GA 30096 US
Baseline Brand NameTRIPLE-PORT GASTROSTOMY CATHETERS
Baseline Generic NameGASTROSTOMY CATHETER
Baseline Model NoNA
Baseline Catalog NoE3320
Baseline IDNA
Baseline Device FamilyGASTROSTOMY CATHETER
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK891371
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1998-11-16

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